Medicines under Additional Monitoring

The European Union has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. These medicines are described as being under 'additional monitoring'. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence explaining what the triangle means. A medecines is placed on this list when for example it has been introduced recently on the market, or if it requires special measures to monitor adverse reactions, or if post-marketing authorisation safety studies were requested by the EMA. All medicines are carefully monitored after they are placed on the EU market. If a medicine is labelled with the black triangle, this means that it is being monitored even more intensively than other medicines. This is generally because there is less information available on it than on other medicines, for example because it is new to the market or there is limited data on its long-term use. There are a few specific cases in which additional monitoring status is always applied, including when a medicine is a biological such as plasma derived medicinal products or vaccine. For more information on medicines under additional monitoring please visit the EMA dedicated webpage here.